Biological E. Limited (BE), established in 1953, is the first private sector biological products company in India and the first pharmaceuticals company in South India. Our mission is to provide affordable access to quality healthcare. The branded formulation business has consistently remained a strong pillar of our organization.

Position Available

Quality Assurance Roles
Location: Shameerpet, Hyderabad

Open Positions:

• Executive / Sr. Executive

Qualifications

• Educational Background:
• B. Pharmacy
• M. Pharmacy
• M. Sc. (Life Science)
• M. Tech. (Life Science)

Required Skills

DS-IPQA (In Process):

• Handling cell or virus culture processes, including bacterial line clearance activities
• Preparation of SOPs, BPRs, MFRs, and protocols for review
• Deviation and change control handling, with knowledge of investigational tools and CAPA management
• OOS/OOT handling and knowledge of analytical document review
• Completion of BPR review and batch release
• Maintenance of the cell/viral bank system
• Validating cleaning and processes

QA-Validation & CSV:

• Validation, qualification, and requalification of HVAC, process and packing equipment, utilities, etc.
• Creating and evaluating URS, DQ, FAT, SAT & SOPs for computerized systems
• Writing reports after preparing and reviewing Computerized Systems Qualification protocols (IQ/OQ/PQ)
• Generating and evaluating System Level Impact Assessments (SLIA)
• Knowledge of 21 CFR Part 11 and EU Annexure 11 compliance

Analytical Quality Assurance (AQA):

• Reviewing SOPs related to Quality Control and stability protocols
• Investigating and closing Out of Limit (OOL), Out of Trend (OOT), and Out of Specifications (OOS)
• Examining equipment logbooks for QC
• Following up on the closure of deviations, change controls, and CAPAs related to the QC area
• Keeping track of OOS, OOT, and OOLs while updating relevant databases and logbooks
• Evaluating protocols, RORs, and reports to verify analytical methods and other studies
• Confirming Media Fill vials
• Reviewing EMP, water trends, specifications, and testing SOPs for materials/products

Walk-In Interview Details

Date: Friday, October 25, 2024
Time: 09:00 AM to 02:30 PM
Venue:
Biological E. Limited
Shankarpalli Road, Patancheru Industrial Area
Patancheru, Hyderabad, Telangana – 502319

Important Notes

• Interested candidates should walk in with the following documents:
• Updated CV
• Latest increment letter
• Last 3 months’ payslips
• Education and other relevant documents
• Please Note: If you have already attended an interview in the past 6 months or have received a job offer from us, do not attend this interview.
• Candidates unable to attend may send their CVs to Careers@Biologicale.com.

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